Biomarker Discovery and Validation in Lung Cancer (LCS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2011 by Public Research Centre Health, Luxembourg
Sponsor:
Information provided by:
Public Research Centre Health, Luxembourg
ClinicalTrials.gov Identifier:
NCT01147562
First received: June 17, 2010
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

Lung cancer is responsible for the most deaths due to cancer each year in both men and women worldwide and once diagnosed, the 10 year survival rate is poor (<15%). This poor prognosis is based in large part on the absence of an effective diagnostic test for the disease. The chief objective of this study is to develop a molecular-based diagnostic test specific for lung cancer. Subjects suspected or diagnosed with lung cancers, who are either undergoing thoracentesis, biopsy of a suspicious lesion or surgical resection of their tumor will be asked to participate in this study. Those subjects, who will undergo surgical resection, will donate both lung tumor tissue and adjacent normal lung tissue (potentially including lymph nodes), while non-surgical candidates will donate a portion of their excess biopsy sample, if available, after diagnosis has been confirmed. Subjects undergoing thoracentesis for pleural effusion will donate a portion of their fluid sample, if the fluid volume collected is in excess of that needed for clinical care purposes. Blood samples and optionally saliva will also be collected from all subjects, whether undergoing surgery or not. In addition to biosample collection, detailed annotated demographic and clinical information will be collected from subjects. Subjects will be followed for outcome analysis, specifically for tumor recurrence, every 6 months, during 5 years. In case of change in chemotherapy treatment, biosamples and clinical information will also be collected. Collected biosamples will be analyzed using a series of molecular and proteomic technologies for developing biomarkers of the disease.


Condition Intervention
Lung Cancer
Procedure: Collection of biospecimen

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Biomarker Discovery and Validation in Lung Cancer

Resource links provided by NLM:


Further study details as provided by Public Research Centre Health, Luxembourg:

Primary Outcome Measures:
  • Discover and validate molecular biomarkers for lung cancer [ Time Frame: Participants are followed up very 6 months up to to 5 years or until death. ] [ Designated as safety issue: No ]
    Investigate markers capable of prediciting response to chemotherapy. In cas a pulmonary nodule is diagnosed and has to be characterized, a biomarker could predict whether the nodule is or is not cancerous and thus, make CT Scan follow up unnecessary.


Estimated Enrollment: 150
Study Start Date: October 2009
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lung Cancer Patients
Patients with a suspected or confirmed diagnosis of lung cancer, whether or not scheduled for lesion biopsy, thoracentesis or surgical resection of their tumor
Procedure: Collection of biospecimen
Collection of saliva, blood and tissues from subjects diagnosed with lung cancer, who are scheduled for biopsy of their lesion or surgical resection of their tumor.

Detailed Description:

The primary objective of this study is to discover and validate molecular biomarkers for lung cancer.

Lung cancer remains the leading cause of cancer death in industrialized countries. Most patients with non-small cell lung cancer (NSCLC) present with advanced disease, and despite recent advances in multi-modality therapy, the overall 10-year survival rate is less than 10%. A significant minority of patients (25−30%) with NSCLC have stage I disease and receive surgical intervention alone. Although 35−50% of patients with stage I disease will relapse within 5 years, it is not currently possible to identify specific high-risk patients. In addition, for patients with metastatic disease, standard chemotherapeutic approaches result in less than 50% response rate, meaning that more than half of patients do not benefit and only suffer from side effects.

Only very limited data exists on markers capable of predicting response to chemotherapy.

This population would certainly also benefit from more of those markers. Another situation where a biomarker could be potentially very useful is the situation where a pulmonary nodule is diagnosed and has to be characterized. In this situation a biomarker could predict whether the nodule is or is not cancerous and thus, make CT Scan follow up unnecessary.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a suspected or confirmed diagnosis of lung cancer, whether or not scheduled for lesion biopsy, thoracentesis or surgical resection of their tumor

Exclusion Criteria:

  • Pregnant women
  • Minors (subjects less than 18 years of age)
  • Prisoners
  • Subjects unable to consent for themselves
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01147562

Contacts
Contact: Guy Berchem, MD +352-44 112084 berchem.guy@chl.lu

Locations
Luxembourg
Clinique Sainte Thérèse (Zithaklinik) Recruiting
Luxembourg, Luxembourg, L-2763
Contact: Georges Decker, MD         
Sub-Investigator: Georges Decker, MD         
Sub-Investigator: Thierry Wagner, MD         
Sub-Investigator: Jean-Claude Schneider, MD         
Centre Hospitalier de Luxembourg (CHL) Recruiting
Luxembourg, Luxembourg, 1210
Contact: Guy Berchem    +352-44 111-1    berchem.guy@chl.lu   
Principal Investigator: Guy Berchem, MD         
Sub-Investigator: Marc Schlesser, MD         
Sub-Investigator: Kamal Abou Hamdan, MD         
Sub-Investigator: Georg Wendt, MD         
Sub-Investigator: Khaled Chalabi, MD         
Sponsors and Collaborators
Public Research Centre Health, Luxembourg
  More Information

Publications:
Responsible Party: Guy Berchem, MD, Centre Hospitalier du Luxembourg
ClinicalTrials.gov Identifier: NCT01147562     History of Changes
Other Study ID Numbers: IBBL0001
Study First Received: June 17, 2010
Last Updated: May 9, 2011
Health Authority: Luxembourg: Comite National d'Ethique de Recherche

Keywords provided by Public Research Centre Health, Luxembourg:
Lung cancer
Biopsy
Biomarker
Tissue Collection

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 16, 2014